�Ardea
Biosciences, Inc. (Nasdaq: RDEA) announced that information was presented
from its completed Phase 2a proof-of-concept monotherapy study of RDEA806,
the Company's novel investigational non-nucleoside reverse transcriptase
inhibitor (NNRTI) for patients with human immunodeficiency virus (HIV),
demonstrating robust antiviral activity with a well-tolerated visibility. An
oral presentation of the data was granted today by Dr. Graeme Moyle, Director
of HIV Research, Chelsea and Westminster Hospital, during a late breaker
session at the XVII International AIDS Conference in Mexico City.
"We are extremely pleased that the last results of the Phase 2a sketch
presented today demonstrate that 800 mg once day-after-day produced like viral
burden reductions as 400 mg twice daily, providing last confirmation that
RDEA806 workings equally well given either once or twice everyday. Based on the
data to date, we continue to consider that RDEA806 has the potential to be a
first-line therapy for the treatment of HIV," aforementioned Barry D. Quart, PharmD,
Ardea's President and CEO. "We look forward to further evaluating RDEA806
and are on track to begin a Phase 2b study comparing once day-to-day doses of
RDEA806 to efavirenz (SUSTIVA(R), Stocrin(R)) in first-line patients
receiving ground treatment with Truvada(R) (emtricitabine and tenofovir
disoproxil fumarate), in the third quarter of this year. A recently
completed drug interaction study with RDEA806 and Truvada confirmed the
want of drug-drug interactions between these agents, paving the way for
initiation of the Phase 2b written report."
The Phase 2a randomized, double-blind, placebo-controlled trial
evaluated the antiviral agent activity, pharmacokinetics, safety and tolerability
of once- and twice-daily oral dosing regimens of RDEA806 versus placebo in
48 HIV-positive patients who were naive to antiretroviral treatment. Nine
out of 12 patients in each of four cohorts received RDEA806. The primary
efficacy end point was the change from baseline in plasma viral payload.
Results from all tetrad cohorts showed a medial reduction in plasma viral
load at nadir of 1.8 - 2.0 log copies/mL. There were no serious adverse
events, premature discontinuations, clinically relevant ECGs changes or
drug-related rash reported in any age bracket. The incidence of CNS side effects
was like between do drugs and placebo. Gastrointestinal position effects were
most uncouth, but these effects were generally transient and mild.
The presentation is uncommitted on the conference site
(http://www.aids2008.org) and on the Company website
(hypertext transfer protocol://www.ardeabio.com) under the title "Antiviral action of RDEA806, a
novel HIV non-nucleoside reverse rNA polymerase inhibitor, in treatment of
naive HIV patients."
About RDEA806 RDEA806 is a novel non-nucleoside blow transcriptase inhibitor
(NNRTI) for the voltage treatment of HIV infection. Based on preclinical
and clinical studies to-date, we believe that RDEA806 may have important
competitive advantages compared to currently available NNRTIs. These
include the potential for potent antiviral agent activity against a wide range of
HIV viral isolates, including those that are repellent to efavirenz
(Sustiva(R)) and other presently available NNRTIs; a high genetic barrier
to resistance; no reproductive toxicity based on beast studies; the
potential to be administered in a patient-friendly, unwritten dosing regimen;
limited pharmacokinetic interactions with other drugs; and the ability to
be co-formulated with other HIV antiviral agent drugs.
About Ardea Biosciences, Inc. Ardea Biosciences, Inc., of San Diego, California, is a ergonomics
company focused on the discovery and development of small-molecule
therapeutics for the treatment of HIV, urarthritis, cancer and inflammatory
diseases. We take four production candidates in clinical trials and others in
preclinical development and discovery. Our most advanced product nominee
is RDEA806, an NNRTI, which has successfully completed a Phase 2a study for
the treatment of patients with HIV. We have evaluated our second-generation
NNRTI for the treatment of HIV, RDEA427, in a human micro-dose
pharmacokinetic study and have selected it for clinical development.
RDEA594, our lead product candidate for the treatment of gout, is in
preclinical development. We are currently evaluating our lead MEK
inhibitor, RDEA119, in a Phase 1 written report in advanced cancer patients and have
completed a Phase 1 study in normal healthy volunteers as a herald to
trials in patients with inflammatory diseases. Lastly, we stimulate evaluated
our second-generation MEK inhibitor for the treatment of genus Cancer and
seditious diseases, RDEA436, in a human micro-dose pharmacokinetic study
and have selected it for clinical development.
Statements contained in this press release regarding matters that are
non historical facts are "innovative statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
dissent materially from those expressed or implied by such forward-looking
statements. Such statements include, simply are non limited to, statements
regarding our goals, including the expected properties and benefits of
RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds and the
results of preclinical, clinical and other studies. Risks that contribute
to the uncertain nature of the forward-looking statements include: risks
related to the issue of presymptomatic and clinical studies, risks related
to regulatory approvals, delays in commencement of preclinical and clinical
studies, and costs associated with our do drugs discovery and development
programs and line of work development activities. These and other risks and
uncertainties are described more fully in our most recently filed SEC
documents, including our Annual Report on Form 10-K and our Quarterly
Reports on Form 10-Q, under the headings "Risk Factors." All
advanced statements contained in this press tone ending speak only if as of
the appointment on which they were made. We undertake no obligation to update such
statements to reflect events that come or luck that exist after
the date on which they were made.
Ardea Biosciences, Inc.
http://www.ardeabio.com
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